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Pluristem Therapeutics Inc Receives Regulatory Approval To Commence Phase I Study Of Pluristem's PLX-PAD Cells For Pulmonary Arterial Hypertension


Thursday, 11 Apr 2013 03:00am EDT 

Pluristem Therapeutics Inc announced that following favorable preclinical studies, United Therapeutics Corporation received approval to perform a human Phase I study in Australia using Pluristem's PLacental eXpanded (PLX-PAD) cells in patients diagnosed with Pulmonary Arterial Hypertension (PAH). United Therapeutics and Pluristem entered into a licensing agreement pursuant to which United Therapeutics will develop, market and sell Pluristem's PLX-PAD cells for PAH. United Therapeutics plans to conduct a single center, open-label, dose-escalation study in patients diagnosed with PAH. The study will enroll up to nine patients in three dosing levels with PLX-PAD cells administered intravenously (IV). The primary endpoint of study is to evaluate the safety of PLX-PAD cells in a follow-up period of one year. Secondary efficacy endpoints at six weeks post-treatment are designed to assess cardio-respiratory function and include six-minute walk distance, cardiac hemodynamic parameters via a right heart catheterization and echocardiogram and pulmonary metabolism via a positron emission tomography (PET) scan. Under terms of Pluristem's licensing agreement with United Therapeutics Corporation, United Therapeutics made an upfront payment of $7 million to Pluristem. Pluristem is also eligible to receive regulatory and other payments totaling up to an additional $48 million with United Therapeutics bearing all the costs of conducting all of the clinical trials for the indication of PAH. 

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